FDA Device recall Z-1171-2026
Genesis Push-In Suture Anchor
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Genesis Push-In Suture Anchor by Aju Pharm, citing reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1171-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-17 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Aju Pharm |
| Distribution | US |
Product
Genesis Push-In Suture Anchor
Reason
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Identifiers
| code_info | Model No. 10S30002; All UDI Codes; All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1171-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.